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Eli Lilly and Company (LLY) Release: Post-Hoc Analysis of Linagliptin Phase 3 Data in Adults With Type 2 Diabetes and Albuminuria Presented


6/11/2012 11:45:39 AM

RIDGEFIELD, Conn. and INDIANAPOLIS, June 9, 2012 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company(NYSE: LLY)today announced results from a post-hoc analysis, which explored the clinical effect of linagliptin on albuminuria in patients with type 2 diabetes who had early diabetic nephropathy (renal disease). The primary endpoint of the analysis was changes to the urinary albumin-to-creatinine ratio (UACR), which is a measure of renal function in patients with type 2 diabetes and diabetic nephropathy.

This post-hoc analysis, which is being presented at the American Diabetes Association's (ADA's) 72nd Scientific Sessions®, included 227 patients with type 2 diabetes and diabetic nephropathy from four randomized, 24-week trials who were on stable treatment with one of two types of blood pressure medicines that are the standard treatment for diabetic renal disease angiotensin-converting enzyme inhibitors (ACEs) and angiotensin receptor blockers (ARBs).[1] The post-hoc analysis showed a 29 percent reduction in UACR with linagliptin plus ACE/ARBs, versus ACE/ARBs alone at 24 weeks (p=0.0305).[1] Since this was a post-hoc analysis, it did not control for other contributing factors. In addition, the linagliptin treatment group reduced glucose levels (as measured by a 0.71 percent change in hemoglobin A1c [HbA1c or A1C] versus the placebo treatment group at 24 weeks; p<0.0001). A1C is measured in people with diabetes to provide an index of blood glucose control for the previous two to three months.

"As these results are based on a post-hoc analysis, this interesting observation warrants further investigation," said John Smith, M.D., Ph.D., senior vice president for clinical development and medical affairs, Boehringer Ingelheim Pharmaceuticals, Inc.

About the Post-hoc Analysis
Data from four randomized, double-blind, 24-week, placebo-controlled trials of linagliptin monotherapy, linagliptin with add-on to metformin, linagliptin with add-on to metformin and sulfonylurea and a factorial study of linagliptin in initial combination with metformin were pooled for the analysis (n=2472) to explore the clinical effect of linagliptin on albuminuria in patients with type 2 diabetes who had early diabetic nephropathy. The primary objectives of these four trials were to evaluate the reduction in A1C from baseline at 24 weeks.[1]

UACR was collected in the four trials as safety data. The endpoint of this post-hoc analysis was the percentage change in the average (mean) UACR. In this analysis, 492 (19.9 percent) patients met UACR (30 to 3,000 mg/g creatinine) and estimated glomerular filtration rate (eGFR; >30 mL/min/1.73 m2) thresholds, of whom 46 percent received stable ACE/ARB therapy (linagliptin n=168; placebo n=59). Mean baseline A1C was 8.2 percent versus 8.5 percent and median baseline UACR was 76 versus 78 mg/g creatinine for the linagliptin and placebo groups, respectively.[1]

The incidence of hypoglycemia was higher in the linagliptin treatment group (14.3%) compared with the placebo treatment group (0%).

Linagliptin is marketed as Tradjenta® 5mg tablets in the U.S.

To learn more about TRADJENTA and for full prescribing information visit: www.TRADJENTA.com, or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257.

What are Tradjenta® (linagliptin) tablets?[2]

TRADJENTA is a prescription medicine that is used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.

TRADJENTA is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).

It is not known if TRADJENTA is safe and effective when used with insulin.

Important Safety Information

Who should not take TRADJENTA?

Do not take TRADJENTA if you are allergic to linagliptin or any of the ingredients in TRADJENTA.

Symptoms of a serious allergic reaction to TRADJENTA arerash, raised red patches on your skin (hives), swelling of your face, lips, and throat that may cause difficulty breathing or swallowing. If you have any symptoms of a serious allergic reaction, stop taking TRADJENTA and call your doctor right away.

What should I tell my doctor before taking TRADJENTA?

TelI your doctor if you take other medicines that can lower your blood sugar, such as a sulfonylurea or insulin.

TRADJENTA may cause serious side effects, including low blood sugar (hypoglycemia). If you take TRADJENTA with another medicine that can cause low blood sugar, such as sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you take TRADJENTA.

Signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, or feeling jittery.

Also tell your doctor if you take rifampin (Rifadin®, Rimactane®, Rifater®, Rifamate®), an antibiotic that is used to treat tuberculosis.

TRADJENTA may affect the way other medicines work, and other medicines may affect how TRADJENTA works.

Tell your doctor if you are pregnant or planning to become pregnant or are breast-feeding or plan to breast-feed.

Tell your doctor about all the medicines you take,including prescription and non-prescription medicines, vitamins, and herbal supplements.

What are the possible side effects of TRADJENTA?

The most common side effects of TRADJENTA include stuffy or runny nose and sore throat.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more safety information, please see Patient Information and full Prescribing Information.

To learn more about TRADJENTA visit: www.TRADJENTA.com. For full prescribing information visit: http://bidocs.boehringer-ingelheim.com/BIWebAccess/ViewServlet.ser?docBase=renetnt&folderPath=/Prescribing+Information/PIs/Tradjenta/Tradjenta.pdf or call Boehringer Ingelheim Pharmaceuticals, Inc. at 1-800-542-6257.

Please report any unexpected effects or product problems to the Boehringer Ingelheim Drug Information Unit by calling 1-800-542-6257.

About Diabetes
Approximately 25.8 million Americans[3] and an estimated 366 million people worldwide[4] have type 1 or type 2 diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diabetes cases.[3] Diabetes is a chronic disease that occurs when the body either does not properly produce, or use, the hormone insulin.[5]

Boehringer Ingelheim and Eli Lilly and Company
In January 2011, Boehringer Ingelheim and Eli Lilly and Companyannounced an alliance in the field of diabetes that centers on four pipeline compounds representing several of the largest treatment classes. This alliance leverages the companies' strengths as two of the world's leading pharmaceutical companies, combining Boehringer Ingelheim's solid track record of research-driven innovation and Lilly's innovative research, experience, and pioneering history in diabetes. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs. Find out more about the alliance at www.boehringer-ingelheim.com or www.lilly.com.

About Boehringer Ingelheim
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 145 affiliates and more than 44,000 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel medications of high therapeutic value for human and veterinary medicine.

As a central element of its culture, Boehringer Ingelheim pledges to act socially responsible. Involvement in social projects, caring for employees and their families, and providing equal opportunities for all employees form the foundation of the global operations. Mutual cooperation and respect, as well as environmental protection and sustainability are intrinsic factors in all of Boehringer Ingelheim's endeavors.

In 2011, Boehringer Ingelheim achieved net sales of about $17.1 billion (13.2 billion euro). R&D expenditure in the business area Prescription Medicines corresponds to 23.5% of its net sales.

For more information, please visit http://us.boehringer-ingelheim.com and follow us on Twitter at http://twitter.com/boehringerus.

About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, IN, Lilly provides answers through medicines and information for some of the world's most urgent medical needs. Additional information about Lilly is available at www.lilly.com.

About Lilly Diabetes
Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we work to meet the diverse needs of people with diabetes through research and collaboration, a broad and growing product portfolio and a continued commitment to providing real solutions-from medicines to support programs and more-to make lives better.

For more information, visit www.lillydiabetes.com.

This press release contains forward-looking statements about TRADJENTA tablets for the treatment of type 2 diabetes. It reflects Lilly's current beliefs; however, as with any such undertaking, there are substantial risks and uncertainties in the process of drug development and commercialization. There is no guarantee that future study results and patient experience will be consistent with study findings to date or that TRADJENTA will be commercially successful. For further discussion of these and other risks and uncertainties, please see Lilly's latest Forms 10-Q and 10-K filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

P-LLY
TJ310500

[1] Groop P-H, Cooper M, Perkovic V, et al. Linagliptin Lowers Albuminuria on Top of Recommended Standard Treatment for Diabetic Nephropathy. Abstract #953-P. Presented at the American Diabetes Association's (ADA's) 72nd Scientific Sessions®. June 8-12, Philadelphia, PA.

[2] Tradjenta® (linagliptin) tablets. Highlights of Prescribing Information. Initial US Approval: 2011.

[3] Centers for Disease Control and Prevention. National diabetes fact sheet: national estimates and general information on diabetes and prediabetes in the United States, 2011. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, 2011.

[4] International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: The Global Burden. 2011. http://www.idf.org/diabetesatlas/5e/the-global-burden. Accessed on: May 18, 2012.

[5] International Diabetes Federation. IDF Diabetes Atlas, 5th Edition: What is Diabetes? http://www.idf.org/diabetesatlas/5e/what-is-diabetes. Accessed on: May 18, 2012.

(Logo: http://photos.prnewswire.com/prnh/20031219/LLYLOGO )

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SOURCE Eli Lilly and Company


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